AbbVie announces positive CHMP opinion for MAVIRET in acute hepatitis C

AbbVie has recently announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of MAVIRET, an oral pangenotypic direct acting antiviral therapy, for the treatment of acute hepatitis C infection in adults and children aged 3 years and older. A final decision from the European Commission is expected in the third quarter of 2026. If approved, MAVIRET would be indicated for both acute and chronic hepatitis C infection across the European Union.

“The CHMP positive opinion for MAVIRET in acute hepatitis C represents an important step toward enabling earlier treatment, at a stage when the disease is often asymptomatic and may go undiagnosed,” said Primal Kaur, M.D., senior vice president, global development of immunology, neuroscience, eye care and specialty at AbbVie. “This milestone aligns with global clinical guidance supporting treatment of suitable people with acute or chronic HCV infection. It also has the potential to help address unmet need, reduce the risk of onward transmission, and support global HCV elimination efforts.”

HCV is a serious blood borne virus that can progress to chronic liver disease when left untreated. Acute infection is often asymptomatic, and many individuals remain unaware they are infected until the disease has reached a later stage. Global clinical guidance supports treating nearly all people with HCV infection, reflecting the value of early diagnosis and timely initiation of therapy. The newly released 2026 WHO Global Hepatitis Report further reinforces this need, noting that diagnosis and treatment coverage remain well below global targets and stressing the importance of earlier testing and rapid linkage to care.

The positive opinion is supported by data from the Phase 3, multicenter, single arm prospective M20-350 study, which evaluated the safety and efficacy of an eight week course of MAVIRET in adults with acute HCV infection. In the study, MAVIRET produced a 96% cure rate, measured by sustained virologic response at 12 weeks after treatment (SVR12), with a safety profile broadly in line with prior experience. The most common adverse events were fatigue, diarrhea, headache, and asthenia.

“In clinical practice, acute HCV can be challenging to manage, as it is often identified incidentally and patients may be lost to follow up before treatment is initiated,” said Prof. Christoph Sarrazin, chief physician at St. Josef’s Hospital Wiesbaden, Germany; head of the Wiesbaden Liver Center; and board member of the German Liver Foundation. “This treatment option could help streamline care pathways and support timely initiation of therapy once infection is confirmed, an important step for both individual patient outcomes and broader public health efforts.”

AbbVie continues to work with global regulatory authorities to expand access to MAVIRET for people living with acute HCV infection. MAVIRET is currently approved in Canada, Australia, the United States (as MAVYRET), Saudi Arabia, New Zealand, Taiwan, and Argentina for the treatment of acute and chronic HCV infection in adults and children aged 3 years and older.

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Related Topics and Keywords

AbbVie, acute hepatitis C, MAVIRET, Positive CHMP Opinion